Stanbio Laboratory, LP recalls
Every recall we track for Stanbio Laboratory, LP — 9 in all, from 2018–2023 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Stanbio Laboratory, LP peaked in 2021 (5); 9 since 2017. 11% rated “stop using now”.
All FDA recall records for Stanbio Laboratory, LP since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 1 | 1 | 0 | 2 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 5 | 0 | 5 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 1 | 0 | 0 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Stanbio Laboratory, LP product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Stanbio Laboratory, LP recalls
5 shown- Stop using nowMedical device
Stanbio Laboratory, LP recalls STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Stanbio Laboratory recalls specific lots of STAT-Site M BHB test strips due to stability issues that may cause false negative results for blood ketone levels.
Stanbio LaboratoryOct 2, 2023 - Lower riskMedical device
Stanbio Laboratory, LP recalls Separation Technology Creamatocrit Plus, Catalog Number: 100-146
Stanbio recalls Creamatocrit Plus breast milk analyzers (2019-2021) due to unvalidated performance as an IVD, risking suboptimal infant nutrition. Affected users should contact for remedy.
StanbioMar 16, 2022 - Lower riskMedical device
Stanbio Laboratory, LP recalls Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Stanbio recalls unlabeled Beta-Hydroxybutyrate Reagent A enzyme for unstable quality control values. This in vitro diagnostic reagent may produce inaccurate test results if used improperly.
StanbioJul 12, 2021 - Lower riskMedical device
Stanbio Laboratory, LP recalls RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry
Stanbio recalls RaPET RF Latex Reagent used in rheumatoid arthritis tests due to weakly positive results in patient serum samples. Affected kits include RaPET RF (1155-100) and others with specific expiry dates.
StanbioFeb 13, 2018 - Use cautionMedical device
Stanbio Laboratory, LP recalls Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint
Stanbio recalls AC power adapters for HemoPoint H2 meters (Model G3000) due to risk of electrical exposure from cracked plugs. Affected units have serial numbers 41800001-41804000.
StanbioFeb 8, 2018
Stanbio Laboratory, LP recall questions
How many recalls has Stanbio Laboratory, LP had?
9 recalls from Stanbio Laboratory, LP are on record with U.S. safety agencies, from 2018–2023.
What is the most recent Stanbio Laboratory, LP recall?
Stanbio Laboratory, LP recalls STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values., dated Oct 2, 2023. Every Stanbio Laboratory, LP recall is listed on this page, newest first.
What should I do if I have a recalled Stanbio Laboratory, LP product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Stanbio Laboratory, LP recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.